- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... globally, coordinating departmental and cross-functional support.Responsibilities Designs and implements regulatory strategies to obtain, maintain product investigative… more
- Merck & Co. (Rahway, NJ)
- …Management Leadership, Product Strategies, Regulatory Affairs Compliance , Regulatory Compliance , Requirements Management, Stakeholder Communications, ... Clinical and Development Digital Solutions (CDDS IT), the Executive Director , Digital Regulatory and Safety, will lead...cases to deliver enterprise value, focusing on innovation, risk, regulatory compliance , and scalability. Act as a… more
- Merck & Co. (Rahway, NJ)
- … development in addition to device development expertise.Strong familiarity with regulatory landscape associated with drug delivery combination product and ... verification testing strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design,… more
- Merck & Co. (Rahway, NJ)
- … product lifecycle management for drug-device combination products.Reporting to the Sr. Director of Device Product Assessment & Innovation (DPAI), the ... Director , Lead of Strategy for Device Product Assessment & Innovation will define and build strategic roadmaps to manage governance, operations, and… more
- Merck & Co. (Rahway, NJ)
- …Program Management, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk Management, Stakeholder ManagementPreferred Skills: ... Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across...of the Value Chain Management Team, guiding strategy, ensuring compliance , and enabling manufacturing excellence from development through commercialization.… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership and Technical ... all activities are conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional and local site… more
- Merck & Co. (Rahway, NJ)
- …experienceRequired Skills: Audit Readiness, Drug Product Manufacturing, FDA Compliance , FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection ... compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.Ability to travel globally approximately 20-30% of the… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across… more
- Merck & Co. (Rahway, NJ)
- …Recruitment, Process Analytical Technology (PAT), Professional Networking, Raw Materials, Regulatory Compliance , Regulatory Submissions, Release Testing, ... entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance ...a state of inspection readiness at all times. The Director should be well engaged with regulatory … more
- Merck & Co. (Rahway, NJ)
- …incumbent contributes to product development and marketing strategies to ensure that product value is defined and developed. The Director also works closely ... Job DescriptionUnder the guidance of the Pneumococcal Vaccines Executive Director , Value & Implementation (V&I) Outcomes Research, the incumbent has the primary… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging Technical Operations organization aims… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the guidance of an Executive Director , within the Value & Implementation (V&I) Outcomes Research team the incumbent has the following ... to obtain in-depth understanding of country specific HTA/reimbursement needs for the product and gain input on research design and implementation of retrospective… more
- Merck & Co. (Rahway, NJ)
- …activities-ensuring integration of HF principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF ... Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary...represent the company externally to influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- SMBC (Jersey City, NJ)
- …+ Lead and contribute to large-scale, cross-functional projects to enhance regulatory compliance infrastructure. + Develop and deliver training materials ... portfolio of benefits to its employees. **Overview** As a Regulatory Policy Director at SMBC you will...in industry forums to discuss capital, liquidity, and other regulatory topics. **Technical Advisory & Product Analysis**… more
- Merck & Co. (Rahway, NJ)
- …Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory Compliance , Regulatory Requirements {+ 3 ... Job DescriptionAssociate Director HVAC : The HVAC Associate Director...Site.Develop, implement, and maintain HVAC operational strategies that ensure compliance with GxP (as applicable) and other regulatory… more
- Merck & Co. (Rahway, NJ)
- …and pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ scientific oversight ... addition to responsibilities associated with clinical research, the Clinical Director at this level will be expected to lead...at this level will be expected to lead a Product Development Team (PDT) through late-phase clinical development and… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities include, but are not limited to: Work closely with the group Director to shape and execute strategy for biological characterization in all stages of ... for characterization of new biologics modalities for structure-function understanding. Champion compliance and safety while promoting a culture of diversity, equity,… more
